Effects of Pre-emptive Scalp Infiltration With Ketorolac and Ropivacaine for Post-craniotomy Pain

Pain Clinical Trial

Official title:

Effects of Pre-emptive Scalp Infiltration With Ketorolac and Ropivacaine for Postoperative Pain Relief After Elective Supratentorial Craniotomy (PAINLESS)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04141319
• Other study ID #: KY-2018-034-02-6
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 2021
• Est. completion date: December 2022

Study information

• Verified date: January 2020
• Source: Beijing Tiantan Hospital
• Contact: Fang Luo, M.D
• Phone: +8613611326978
• Email: 13611326978[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The PAINLESS study is a single-center, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled clinical study to compare the efficacy and safety of pre-emptive scalp infiltration with ropivacaine plus ketorolac and ropivacaine alone for postoperative pain relief in adults undergoing elective supratentorial craniotomies.

Description:

The proposed study will be a single-center, prospective, randomized, open-label, blinded-endpoint clinical trial designed to test the hypothesis that the addition of ketorolac to pre-emptive scalp infiltration analgesia can significantly improve analgesia after craniotomies. One hundred participants will be randomized to the ketorolac group or the control group. Patients in the ketorolac group will receive pre-emptive scalp infiltration with opivacaine,ketorolac and epinephrine while patients in the control group will receive pre-emptive scalp infiltration with ropivacaine and epinephrine.The primary outcome measure will be cumulative doses of patient-controlled analgesia (PCA) butorphanol consumption from 0 to 48 h postoperatively.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Scheduled for elective supratentorial tumour resection;

• Planned general anaesthesia;

• American Society of Anesthesiologists (ASA) physical status I - II;

• Age ranging from 18 to 65 years old;

• Participates required to fix their head in a head clamp intraoperatively;

• Participates with an anticipated awake within 2 hours after surgery.

Exclusion Criteria:

• Allergy/intolerance to study drugs including anesthetic drugs, ketorolac and epinephrine;

• Expected delayed extubation or no plan to extubate;

• History of neurosurgeries;

• Long-term use of analgesics and sedatives (more than 2 weeks)

• Receiving any painkiller within 24 h before the operation;

• Extreme body mass index (BMI) (less than 15 or more than 35);

• Patients with impaired cardiopulmonary;

• Patients with impaired renal function;

• Patients with impaired hepatic function;

• History of chronic headache;

• Patients with cognitive deficit;

• Patients with intellectual disability;

• Patients with uncontrolled epilepsy;

• Patients with psychiatric disorders;

• Difficulties in using PCA device

• Difficulties in understanding the use of numeral rating scale (NRS) ;

• Patients with suspected intracranial hypertension;

• Pregnant or at breastfeeding;

• Infection at the incisional site;

• History of radiation therapy and chemotherapy preoperatively

• With great likelihood of postoperative radiation therapy and chemotherapy based on preoperative imaging.

Related Conditions & MeSH terms

• Brain Neoplasms
• Pain
• Supratentorial Brain Tumor

Intervention

Drug:
• Ketorolac
30ml of local infiltration solution containing 60mg ropivacaine
• Ropivacaine
30ml of local infiltration solution containing 6mg ketorolac
• Epinephrine
30ml of local infiltration solution containing 0.1mg epinephrine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

References & Publications (4)

Andersen KV, Nikolajsen L, Haraldsted V, Odgaard A, Søballe K. Local infiltration analgesia for total knee arthroplasty: should ketorolac be added? Br J Anaesth. 2013 Aug;111(2):242-8. doi: 10.1093/bja/aet030. Epub 2013 Mar 20. — View Citation

Solovyova O, Lewis CG, Abrams JH, Grady-Benson J, Joyce ME, Schutzer SF, Arumugam S, Caminiti S, Sinha SK. Local infiltration analgesia followed by continuous infusion of local anesthetic solution for total hip arthroplasty: a prospective, randomized, double-blind, placebo-controlled study. J Bone Joint Surg Am. 2013 Nov 6;95(21):1935-41. doi: 10.2106/JBJS.L.00477. — View Citation

Song J, Li L, Yu P, Gao T, Liu K. Preemptive scalp infiltration with 0.5% ropivacaine and 1% lidocaine reduces postoperative pain after craniotomy. Acta Neurochir (Wien). 2015 Jun;157(6):993-8. doi: 10.1007/s00701-015-2394-8. Epub 2015 Apr 7. — View Citation

Vacas S, Van de Wiele B. Designing a pain management protocol for craniotomy: A narrative review and consideration of promising practices. Surg Neurol Int. 2017 Dec 6;8:291. doi: 10.4103/sni.sni_301_17. eCollection 2017. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative doses of patient-controlled analgesia (PCA) butorphanol consumption from 0 to 48 h postoperatively	The primary outcome measure will be cumulative doses of PCA butorphanol consumption from 0 to 48 h postoperatively	0 to 48 hours postoperatively
Secondary	The time to first request for patient-controlled analgesia butorphanol	The time to first request for patient-controlled analgesia butorphanol	Within 48hours postoperatively
Secondary	frequency of pressing patient-controlled analgesia pump	frequency of patient-controlled analgesia pump	Within 48hours postoperatively
Secondary	numeral rating scale (NRS) Score	0 for"no pain" and 10 for "'pain as severe as you can imagine"	at 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months and 6 months postoperatively
Secondary	Pain control satisfaction score (PCSS) postoperatively	0 for unsatisfactory and 10 for very satisfactory	at 24 hours, 48 hours, 72 hours, 1 week, 1 month, 3 months and 6 months
Secondary	Ramsay sedation score (RSS)	1: Anxious, agitated, restless; Ramsey 2: Cooperative, oriented, tranquil; Ramsey 3: Responsive to commands only If Asleep; Ramsey 4: Brisk response to light glabellar tap or loud auditory stimulus; Ramsey 5: Sluggish response to light glabellar tap or loud auditory stimulus; Ramsey 6: No response to light glabellar tap or loud auditory stimulus.; Asleep; Ramsey 4: Brisk response to light glabellar tap or loud auditory stimulus; Ramsey 5: Sluggish response to light glabellar tap or loud auditory stimulus; Ramsey 6: No response to light glabellar tap or loud auditory stimulus.	at 2 hours, 4 hours, 8 hours, 24 hours and 48 hours and 72 hours postoperatively
Secondary	pulse oxygen saturation(SpO2)	SpO2	1 minutes before anesthesia induction, 1 minutes after anesthesia induction, 1 minutes after scalp infiltration, at the beginning of skull drilling, mater cutting and skin closure and at 2hours, 4 hours, 8 hours , 24 hours and 48 hours postoperatively
Secondary	mean arterial blood pressure(MAP)	MAP	1 minutes before anesthesia induction, 1 minutes after anesthesia induction, 1 minutes after scalp infiltration, at the beginning of skull drilling, mater cutting and skin closure and at 2hours, 4 hours, 8 hours , 24 hours and 48 hours postoperatively
Secondary	heart rate(HR)	HR	1 minutes before anesthesia induction, 1 minutes after anesthesia induction, 1 minutes after scalp infiltration, at the beginning of skull drilling, mater cutting and skin closure and at 2hours, 4 hours, 8 hours , 24 hours and 48 hours postoperatively
Secondary	respiratory rate(RR)	RR	1 minutes before anesthesia induction, 1 minutes after anesthesia induction, 1 minutes after scalp infiltration, at the beginning of skull drilling, mater cutting and skin closure and at 2hours, 4 hours, 8 hours , 24 hours and 48 hours postoperatively
Secondary	Length of hospital stay	Length of hospital stay	Length of hospital stay, an arverage of 2 weeks
Secondary	Wound healing score	Skin Healing 1: fully healed; 2: =3 cm in total not healed; 3: >3 cm not healed; 4: areas of necrosis =3 cm; 5: areas of necrosis >3 cm Infection 1: none; 2: =0.5-cm margin of redness; 3: more redness or superficial pus; 4: deep infection; not applicable Hair Regrowth 1: even regrowth along wound; 2: =3 cm not regrowing; 3: >3-6 cm not regrowing; 4: >6 cm not regrowing; not applicable	at 3 weeks and 6 weeks after surgery
Secondary	postoperative nausea and vomiting(PONV)	0, absent; 1, nausea but not requiring treatment; 2, nausea requiring treatment; and 3, vomiting	within 48 hours postoperatively
Secondary	The presence of respiratory depression	respiratory rate <10 breaths per minute or SpO2 was<90 %	within 48 hours postoperatively
Secondary	The incidence of haematoma, wound infection or gastric ulcers	side effects	during hospitalization, within 2 weeks postoperatively